Designation D4840 − 99 (Reapproved 2010) Standard Guide for Sample Chain of Custody Procedures1 This standard is issued under the fixed designation D4840; the number immediately following the designat[.]
Trang 1Designation: D4840−99 (Reapproved 2010)
Standard Guide for
This standard is issued under the fixed designation D4840; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision A number in parentheses indicates the year of last reapproval A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1 Scope
1.1 This guide contains a comprehensive discussion of
potential requirements for a sample chain-of-custody program
and describes the procedures involved in sample
chain-of-custody The purpose of these procedures is to provide
account-ability for and documentation of sample integrity from the time
samples are collected until sample disposal
1.2 These procedures are intended to document sample
possession during each stage of a sample’s life cycle, that is,
during collection, shipment, storage, and the process of
analy-sis
1.3 Sample chain-of-custody is just one aspect of the larger
issue of data defensibility (see 3.2.2andAppendix X1)
1.4 A sufficient chain-of-custody process, that is, one that
provides sufficient evidence of sample integrity in a legal or
regulatory setting, is situationally dependent The procedures
presented in this guide are generally considered sufficient to
assure legal defensibility of sample integrity In a given
situation, less stringent measures may be adequate It is the
responsibility of the users of this guide to determine their exact
needs Legal counsel may be needed to make this
determina-tion
1.5 Because there is no definitive program that guarantees
legal defensibility of data integrity in any given situation, this
guide provides a description and discussion of a
comprehen-sive list of possible elements of a chain-of-custody program, all
of which have been employed in actual programs but are given
as options for the development of a specific chain-of-custody
program In addition, within particular chain-of-custody
elements, this guide proscribes certain activities to assure that
if these options are chosen, they will be implemented properly
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use It is the
responsibility of the user of this standard to establish
appro-priate safety and health practices and determine the
applica-bility of regulatory limitations prior to use.
2 Referenced Documents
2.1 ASTM Standards:2 D1129Terminology Relating to Water
D3325Practice for Preservation of Waterborne Oil Samples
D3370Practices for Sampling Water from Closed Conduits
D3694Practices for Preparation of Sample Containers and for Preservation of Organic Constituents
D3856Guide for Management Systems in Laboratories Engaged in Analysis of Water
D4210Practice for Intralaboratory Quality Control Proce-dures and a Discussion on Reporting Low-Level Data
(Withdrawn 2002)3 D4841Practice for Estimation of Holding Time for Water Samples Containing Organic and Inorganic Constituents
2.2 U.S EPA Standard:
U.S EPAGood Automated Laboratory Practices4
3 Terminology
3.1 Definitions—For definitions of terms used in this guide,
refer to TerminologyD1129
3.2 Definitions of Terms Specific to This Standard: 3.2.1 custody—physical possession or control A sample is
under custody if it is in possession or under control so as to prevent tampering or alteration of its characteristics
3.2.2 data defensibility—a process that provides sufficient
assurance, both legal and technical, that assertions made about
a sample and its measurable characteristics can be supported to
an acceptable level of certainty See Appendix X1 for a discussion of the elements of a data defensibility process
3.2.3 sample—a portion of an environmental or source
matrix that is collected and used to determine the characteris-tics of that matrix
1 This guide is under the jurisdiction of ASTM Committee D19 on Water and is
the direct responsibility of Subcommittee D19.02 on Quality Systems, Specification,
and Statistics.
Current edition approved Feb 1, 2010 Published March 2010 Originally
approved in 1988 Last previous edition approved in 2004 as D4840 – 99 (2004).
DOI: 10.1520/D4840-99R10.
2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 The last approved version of this historical standard is referenced on www.astm.org.
4 Available from U.S Government Printing Office Superintendent of Documents,
732 N Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// www.access.gpo.gov.
Trang 23.2.4 sample chain-of-custody—a process whereby a sample
is maintained under physical possession or control during its
entire life cycle, that is, from collection to disposal
3.2.5 sample chain-of-custody record— documentation
pro-viding evidence that physical possession or control was
main-tained during sample chain-of-custody
4 Summary of Guide
4.1 This guide addresses chain-of-custody procedures as
they relate to field practices, shipping methods, and laboratory
handling of samples
5 Significance and Use
5.1 Chain-of-custody procedures are a necessary element in
a program to assure one’s ability to support data and
conclu-sions adequately in a legal or regulatory situation, but custody
documentation alone is not sufficient A complete data
defen-sibility scheme should be followed
5.2 In applying the sample chain-of-custody procedures in
this guide, it is assumed that all of the other elements of data
defensibility have been applied, if applicable
6 Procedure
6.1 Facility Chain-of-Custody Standard Operating
Procedure—Each organization should have a chain-of-custody
procedure document This document should spell out in detail
the specific procedures utilized at this facility to achieve
sample chain-of-custody It should contain copies of all the
forms used in the chain-of-custody process and detailed
instructions for their use It should be kept current and
revisions tracked This guide may serve as a template for the
chain-of-custody procedure document
6.2 Sample Collection Phase:
6.2.1 Custody Assignment—A single field sampling person
should be assigned responsibility for custody of samples An
alternate custodian should also be assigned to cover the prime
custodian’s absence As few people as possible should handle
samples The assigned field sampler should be personally
responsible for the care and custody of the samples collected
until they are properly transferred While samples are in their
custody, field personnel should be able to testify that no one
was able to tamper with the samples without their knowledge
6.2.2 Documentation/Field Custody Forms:
6.2.2.1 Standard forms should be designed and available for
recording custody information related to field sample handling
The forms may be designed to handle one sample or multiple
samples A single sample form may allow room for laboratory
chain-of-custody
6.2.2.2 In any sampling effort, there is field information
related to sample collection and field measurements that are
recorded This information is not specifically part of
chain-of-custody, but part of the larger aspect of data defensibility This
information may be recorded on chain-of-custody forms or
other forms specific for the purpose Record keeping may be
simplified if separate forms are used
6.2.2.3 It may be useful to print field forms on polyethylene
or other plastic coated paper to keep them from being affected
by water or chemicals An indelible ink, paint, or crayon should
be used to enter information on the forms
6.2.2.4 Spaces for the following information should be on the form:
(a) Sample identifying name.
(b) Sampling location ID, sampling point ID, date, and
sampling time interval
(c) Signatures of sampling personnel and signatures of all
personnel handling and receiving the samples
(d) Project identification code (if applicable).
(e) Preservation (to alert lab personnel): amount and type (f) Number of containers (where field sub-sampling
oc-curs) Indicate number of replicates if there are multiple containers of the same sample
(g) Field notes.
(h) Analyses desired (may be required in some situations) (i) Sample type: grab, composite, etc.
Example forms are shown inAppendix X2 6.2.2.5 Freight bills, post office receipts, and bills of lading should be retained as part of the permanent custody documen-tation
6.2.3 Sample Labeling:
6.2.3.1 Sample labels may be in the form of adhesive labels
or tags, or both Tags have the advantage of being removable to become part of the record keeping process, although their inadvertent loss or inappropriate removal may leave the sample without documentation Labels should be made of waterproof paper and indelible ink should be used to make entries Alternatively, sample information may be written directly on the sample container, as long as the writing can be done indelibly Containers should be free from other labels and other writing to prevent any confusion If both tags and labels are used, care should be taken to ensure that the information on both is identical
6.2.3.2 Labels or tags should be filled out just before or immediately after sample collection Labels should contain spaces for the following information:
(a) Project identification code (if applicable).
(b) Sample identifying name (exactly as it appears on the
chain-of-custody record)
(c) Sampling location ID, sampling point ID, and sampling
time interval
(d) Safety considerations (if applicable).
(e) Analysis schedule or schedule code (if applicable) (f) Company or agency name.
An example label is shown inAppendix X2
6.2.4 Sample Sealing:
6.2.4.1 Sample custody seals of waterproof adhesive paper may be used to detect unauthorized tampering with samples prior to receipt by the lab When seals are used, they shall be applied so that it is necessary to break them in order to open the sample container
6.2.4.2 Electrical (vinyl) tape may be used to prevent bottle closures from loosening in transit Tape should be applied before any custody seals are applied
N OTE 1—Electrical tape should not be used to seal vials used for volatile organic analyses due to the potential for sample contamination.
6.2.5 Field Transfer of Custody and Shipment:
Trang 36.2.5.1 Package samples properly for shipment and
trans-port them to the laboratory for analysis Special care should be
taken when packaging in glass It is important that all laws and
regulations related to the transport of materials have been
adequately addressed before shipping samples
6.2.5.2 When employing a common carrier, the use of
padlocks or custody seals on shipping containers should be
considered If padlocks are employed, the keys shall be shipped
separately from the samples Alternatively, padlocks may be
sent unfastened to the field and the keys can be retained by the
laboratory sample custodian (see 6.3.2.1) A separate custody
record should accompany each shipment Enter the method of
shipment, courier name(s), and other pertinent information in
the “remarks” section on the custody record
6.2.5.3 If sent by mail, register the package with return
receipt requested
6.2.5.4 When transferring the possession of samples, the
individuals relinquishing and the individuals receiving the
samples should sign, date, and note the time on the custody
record Document any opening and closing of the sample
containers on the custody record Provisions should be made
for receipt of samples at nonstandard hours, such as nights and
weekends by nonlaboratory personnel Shipping documents,
with noted time of receipt and receipt by whom, should be
made part of the custody record
6.3 Laboratory Handling and Analysis Phase:
6.3.1 Documentation—Laboratory Custody Forms:
6.3.1.1 The sample chain-of-custody record in the
labora-tory is traditionally maintained on paper forms Based on the
data defensibility needs of the organization, it may be possible
to maintain the laboratory record in an electronic format
Various computer systems, such as a laboratory information
management systems (LIMS) or other electronic data
manage-ment systems, may meet the data integrity needs It is the
responsibility of each organization to assure that an electronic
record system meets these needs Users of such systems are
encouraged to assure compliance of their electronic data
system with the U.S EPA Good Automated Laboratory
Prac-tices All references to laboratory custody record forms in this
guide should be understood to refer to either paper or electronic
documents
6.3.1.2 Design a form for the recording of chain-of-custody
information related to sample possession in the laboratory If
samples are to be split and distributed to multiple analysts,
multiple forms will be needed to accompany the sample splits
Transfer sample identification information to the forms
accom-panying the splits exactly as it appears on the primary receipt
laboratory chain-of-custody form If an LIMS label is used for
the sample splits, a duplicate should be placed on the
chain-of-custody form that accompanies them Example forms are
shown inAppendix X2
6.3.2 Laboratory Sample Receipt and Handling:
6.3.2.1 In the laboratory, assign a sample custodian(s) to
receive the samples It is preferable to assign one person the
primary responsibility to receive samples as the sample
custo-dian for the laboratory A second person should serve only as
an alternate
6.3.2.2 Upon receipt of a sample, the custodian should inspect the condition of the sample and the custody sample seal, if used If sample seals are used, record condition on chain-of-custody record Reconcile the information on the sample label against that on the chain-of-custody record The temperature of the samples should be recorded on the chain-of-custody record If samples are not delivered in a cooler, indicate on record If pH adjustment to preserve the sample was done in the field, the pH of the samples should be checked and recorded on the chain-of-custody record
6.3.2.3 If a sample container is leaking, note it on the custody record The custodian, along with the supervisor responsible for the analytical work, should decide whether the leaky sample is valid If seals are used, the custodian should examine whether the sample seal is intact or broken, since a broken seal may mean sample tampering and may make analytical results inadmissible as evidence in court Any discrepancies between the information on the sample label and seal and the information on the chain-of-custody record should
be resolved before the sample is assigned for analysis This effort might require communication with the sample collector Record the results of any such investigation
6.3.2.4 After processing the sample, (splitting, logging, preserving) record all sample splits on the laboratory chain-of-custody form When the sample is logged, the sample identi-fying information should be transcribed exactly as it appears on the field chain-of-custody form If custody transfer to analyti-cal staff will not occur immediately or if sample processing is delayed, the samples should be transferred to the custody lockup (see6.3.3) Record all transfers to and from a lockup on the chain-of-custody form The custody form should remain with the sample
6.3.3 Laboratory Security:
6.3.3.1 In some situations, legally defensible custody in the laboratory has been achieved without regulating possession within the laboratory but rather by assuring controlled and restricted access to the laboratory facility through keying, guarding access points, and other measures Sufficiency of security measures for legal defensibility can only be assessed
on a case by case basis and should involve legal counsel 6.3.3.2 Within the laboratory, a secure, locked location (a refrigerator or freezer), if appropriate, should be available Multiple locations may be necessary to provide access to analysts after they receive their portions of the sample 6.3.3.3 Limit the number of keys to locked locations and maintain control over them Limiting keys to laboratory supervisors or providing multiple lockups assigned to specific analysts are appropriate options Limiting access to samples provides greater security against accidental mishandling of samples
6.3.3.4 As an alternative to secure lockups, tamperproof seals may also be used in the laboratory Note any application
of seals and their removal on the chain-of-custody forms
6.3.4 Analyst Sample Receipt and Handling:
6.3.4.1 When analytical staff take possession of their samples or sample aliquots, they should acknowledge receipt
on the primary laboratory chain-of-custody form
Trang 46.3.4.2 When an analyst takes possession of a sample split,
he or she should also receive the accompanying
chain-of-custody form At that time, the analyst should inspect the
condition of the sample and the sample seal, if used, and
reconcile the information on the sample label against that on
the chain-of-custody form
6.3.4.3 While a sample is in their custody, analysts should
be able to testify that no one tampered with the sample without
their knowledge If the sample, a portion of the sample, or
processed sample such as a digestate will be held for an
extended period of time, the analyst should store it in a security
lockup and record all such transfers on the chain-of-custody
form
6.3.4.4 At such time as there is no further need for the
sample, it should be disposed of properly and the disposal
recorded If the sample or processed sample is to be retained,
it may be transferred to appropriate personnel This transfer
should be recorded on both the analyst custody form and the
primary laboratory custody form The primary custody form
then accompanies the sample until its disposal
6.3.5 Interlaboratory Transfer:
6.3.5.1 On some occasions, another laboratory will be
performing analytical work that is not directly a part of the
project plan, that is, data from this laboratory is not planned to
be part of the data defensibility scheme An example might be
when a facility discharge is being monitored and the facility
laboratory wishes a split of the sample Under these circumstances, the chain-of-custody record remains with the owner Prepare a receipt (an example receipt is shown in Appendix X2) for these samples and mark to indicate with whom the samples are being split The person relinquishing the samples to the other laboratory should request the signature of
a representative of the appropriate party acknowledging receipt
of the samples If a representative is unavailable or refuses to sign, note this in the“ received by” section Complete this form and give a copy to the owner, operator, or agent in charge The original is retained by the project supervisor When appropriate, as in the case where the representative is unavailable, the custody record should contain a statement that the sample splits were delivered to the designated location at a designated time
6.3.5.2 On some occasions, the sample may have to be split with another laboratory in order to obtain all of the necessary analytical information required in the study plan In this case, identical chain-of-custody procedures should be employed at the alternate laboratory Transfer of custody of the split should
be handled in like fashion to that used to an intralaboratory transfer (see6.3.4)
7 Keywords
7.1 chain of custody; custody; data defensibility; validation
APPENDIXES
(Nonmandatory Information) X1 DISCUSSION OF THE ELEMENTS OF DATA DEFENSIBILITY
X1.1 Data defensibility can be thought of as “proof” that a
sample represents the material from which it was taken; that
the sample integrity was maintained; that the measurements
made on the sample produced valid results; and, that the
documentation of the “proof” (custody records, data sheets,
etc.) is a factual record Data defensibility involves the
following:
X1.1.1 The use of proper procedures (for sample collection,
preservation, analysis, etc.),
X1.1.2 Protection of samples from inappropriate alteration
(from tampering, loss, mishandling, etc.), that is,
chain-of-custody,
X1.1.3 The use of proper record collection, record handling,
and record security procedures, and
X1.1.4 Accurate documentation of all sample related
infor-mation
X1.2 There are six principal elements of data defensibility
besides chain-of-custody For a discussion of many of these
elements, see Data Validation in GuideD3856
X1.2.1 Project Setup and Preparation—The production of
data on environmental and source samples for the purpose of
drawing valid conclusions requires good experimental design
Aspects of the project from sample collection to data interpre-tation shall be designed from a valid model
X1.2.2 Measurement Methods—Measurements, both field
determinations and lab analyses, shall be made using validated techniques with known levels of uncertainty Use of methods such as those produced by ASTM Committee D19 can provide assurance that the procedures used will produce useful infor-mation
X1.2.3 Sample Collection Methods—Sample results can
only be as good as the sample analyzed It is vital that the sample analyzed be representative of the designated variables
in the environmental matrix of concern It should not be inferred that the experimental design is appropriate or repre-sentative for any other environmental variables than those designated in the experimental design Containers shall be made of appropriate materials and properly cleaned See Practices D3370, specific test methods, and other practices related to sampling procedures for more information
X1.2.4 Sample Processing and Handling Methods—During
the course of a sample’s life cycle, a variety of sample processing techniques shall be employed, such as sample splitting and preservation Valid procedures shall be employed
Trang 5to maintain sample integrity See Practices D4841, D3694,
D3325, and specific test methods for more information
X1.2.5 Data Recording, Archiving, and Retrieval
Methods—Information collected and observations made shall
be correctly, legibly, and safely recorded After a project is
completed and information recorded, it is important that this
record be safe from tampering and can be reliably retrieved
X1.2.6 Quality Control and Quality Assurance Procedures—During stages of information generation,
pro-cesses shall be maintained in a state of statistical control so that data uncertainties can be quantified In addition, there shall be an“ external” audit procedure to assure that the quality control procedures are effective See Guide D3856, Practice D4210, and specific test methods for more information
X2 EXAMPLE FORMS
X2.1 See sample forms inFigs X2.1-X2.5
FIG X2.1 Example of Sample Identification Tag
Trang 6FIG X2.2 Example of Field Sample Chain of Custody Record
FIG X2.3 Example of Receipt for Samples
Trang 7FIG X2.4 Example Field, Laboratory Receipt, and Laboratory Sample Chain-of-Custody Record (Two-Sided)
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FIG X2.5 Side Two of Custody Record